江西省仿制药一致性评价工作进展及展望

目的分析江西省仿制药一致性评价工作现状,为涉及一致性评价的相关企业与部门提供参考。方法检索国家药品监督管理局-国产药品数据库、丁香园Insight数据库、国家药品监督管理局药品审评中心化学药品目录集专栏、上海阳光采购平台等,归纳总结江西省化学仿制药的品种信息、一致性评价进展、国家药品集中采购及参比制剂公布等情况。结果截至2023年3月28日,江西省辖区内已取得化学仿制药批准文号2143个,占全国比例大约2.5%,涉及品种754个,品规1166个;通过(含视同通过)一致性评价批准文号62个,占全国比例为1.2%;纳入国家药品集中采购的批准文号12个;已公布参比制剂批准文号398个,占整个江西省批准文号的18.6%。结论江西省仿制药一致性评价进展较缓慢,仍有较大的发展空间。

液体石蜡乳制备方法的改进

液状石蜡乳为超声检查用耦合剂,有关操作规程手册[1]都采用研钵法制备.该方法操作既费时又费力,笔者对其制备方法进行了改进,并取得了满意的效果.现介绍如下:处方:液状石蜡500ml,西黄蓍胶12 g,聚山梨酯8 020 ml,乙醇20 ml,苯甲酸钠4 g,蒸馏水适量,全量1000ml.

新型吡喹酮薄膜衣片治疗日本血吸虫病的副反应及疗效研究

目的了解新型吡喹酮薄膜衣片治疗日本血吸虫病的副反应状况及治疗效果。方法在湖北、江西、安徽血吸虫病流行区选择6-65岁的常住居民进行问卷调查、间接血凝免疫诊断试剂筛查，血检阳性者进行改良加藤法检查以确诊。对血检阳性者及部分自愿服药的正常人共计509名给服吡喹酮并调查药物的味道，对460例服药前无副反应相关症状的化疗对象随访副反应情况，对104例粪检阳性者在化疗后3个月进行疗效考核。结果84．7％（144／170）的被调查者认为新型吡喹酮薄膜衣片没有味道或者很轻，而吡喹酮素片对照组有92．9％（315／339）的被调查者认为药物味道较重。在化疗后1～2h，新型吡喹酮薄膜衣片化疗组副反应率为20．30％（27／133），吡喹酮素片对照组副反应率为83．18％（272／327），两化疗组间副反应率具有统计学意义（χ^2=164．316，P〈0．05）。其中新型吡喹酮薄膜衣片化疗组在神经肌肉系统、消化系统、心血管系统的副反应率分别为15．79％（21／133）、9．77％（13／133）、2．26％（3／133），而吡喹酮素片对照组在神经肌肉系统、消化系统、心血管系统的副反应率分别为81．65％（267／327）、49．24％（161／327）、12．84％（42／327），3个系统的副反应率在两化疗组间均具有统计学意义（χ^2神经肌肉系统=175．188，χ^2消化系统=62．601，χ^2心血管系统=12．010，P值均〈0．05）；吡喹酮薄膜衣片化疗组、素片对照组过敏反应发生率分别为2．26％（3／133）、0．92％（3／327），两者之间无统计学意义（χ^2=1．315，P=0．235）。化疗后第2天吡喹酮薄膜衣片化疗组和素片对照组的副反应率分别下降为3．01％（4／133）、38．53％（126／327），两组间存在统计学意义（χ^2=58．852，P〈0．05）。在化疗后2周新型吡喹酮薄膜衣片化疗组、素片对照组的副反应率均已分别下降为0．75％（1／133）、0．61％（2／327），两组间已无统计学意义（χ^2=0．029，P=0．642）。化疗后3个月新型吡喹酮薄膜衣片化疗组、素片对照组的粪检阴转率分别为84．91％（45／51）、82．35％（42／53），两组间无统计学意义（χ^2=1．536，P=0．215）。结论新型吡喹酮薄膜衣片降低了味道及化疗对象的副反应发生率，其疗效与吡喹酮素片对照组等效。在进一步扩大现场验证的基础上，可在血吸虫病流行区推广使用。

The impacts of national essential medicine policies on the rational use of medicines in China: A cross-sectional study in primary health care institution

Irrational use of medicines is a major problem worldwide, and it is believed there would be positive correlation between the National Essential Medicines Policies(NEMPs) and the level of rational use of medicines(RUMs). Though there is some early evidence on the NEMPs’ effects on RUMs in China, the evidence is scarce, and conclusions vary. In the present study, we aimed to evaluate the impacts of the NEMPs of China on the RUMs in the primary health care institutions(PHCs). A cross-sectional survey was conducted in 2010. A total of 201 PHCs from six provinces of China were selected, and 39 181 prescriptions were extracted from January to June, 2010. Six indicators were used and tested by independent-samples T test. We found that the average number of drugs per prescription in PHCs with NEMP implementation(the treatment group) was significantly higher than that of the group without NEMP implementation(the control group)(3.37 vs. 2.83, P<0.01). There was no significant difference in the average cost per prescription(81.43 vs. 75.02). The percentage of prescriptions, including an antibiotic(53.40% vs. 36.48%, P<0.01) or an injection(40.54% vs. 27.94%, P<0.01), was higher in the treatment group, and the percentage of drugs prescribed by general name was significantly lower(83.71% vs. 93.11%, P<0.01). For the percentage of drugs prescribed from essential medicines list, the treatment group exhibited the higher ratio(76.12% vs. 53.45%, P<0.01). From this study, the NEMPs were not likely to have a positive impact on RUMs. China still needed efforts to improve the selection, the absence of physicians’ active involvement, and the patients’ habits of irrational medication use.